MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2001-06-12 for DISPOSABLE ACTIVE CORD DAC manufactured by Circon Acmi.
[223823]
So the cord would not "flop" in the way during the procedure, the surgeon reportedly asked the scrub nurse to clamp the cord to the drape. During the procedure, the pt was burned on the leg approximately 1' from the resection block.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-2001-00041 |
| MDR Report Key | 338538 |
| Report Source | 05,06,07 |
| Date Received | 2001-06-12 |
| Date of Report | 2001-06-12 |
| Date of Event | 2001-05-29 |
| Date Mfgr Received | 2001-06-12 |
| Date Added to Maude | 2001-06-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARY PICKARD |
| Manufacturer Street | 300 STILLWATER AVE |
| Manufacturer City | STAMFORD CT 06902 |
| Manufacturer Country | US |
| Manufacturer Postal | 06902 |
| Manufacturer Phone | 2033288721 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE ACTIVE CORD |
| Generic Name | ACTIVE CORD |
| Product Code | FFZ |
| Date Received | 2001-06-12 |
| Returned To Mfg | 2001-06-12 |
| Model Number | DAC |
| Catalog Number | DAC |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 327842 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 93 NORTH PLEASANT ST. NORWALK OH 448570409 US |
| Baseline Brand Name | DISPOSABLE ACTIVE CORD |
| Baseline Generic Name | ACTIVE CORD |
| Baseline Model No | DAC |
| Baseline Catalog No | DAC |
| Baseline ID | NA |
| Baseline Device Family | ACTIVE CORD |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-06-12 |